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MYDCOMBI Drug Patent Profile

When do Mydcombi patents expire, and what generic alternatives are available?

Mydcombi is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mydcombi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYDCOMBI

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in MYDCOMBI?	MYDCOMBI excipients list
DailyMed Link:	MYDCOMBI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYDCOMBI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215352

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MYDCOMBI

Drug Class	Anticholinergic alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MYDCOMBI

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for MYDCOMBI

MYDCOMBI is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MYDCOMBI

FDA Regulatory Exclusivity protecting MYDCOMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes

International Patents for MYDCOMBI

See the table below for patents covering MYDCOMBI around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2835886
Japan	5964826
Eurasian Patent Organization	201390120	ДОСТАВКА ОФТАЛЬМОЛОГИЧЕСКИХ ЛЕКАРСТВЕННЫХ СРЕДСТВ
Eurasian Patent Organization	201390121	СПОСОБ И СИСТЕМА ДЛЯ ВЫПОЛНЕНИЯ ДИСТАНЦИОННОГО ЛЕЧЕНИЯ И КОНТРОЛЯ
Japan	6039719
South Africa	201301154	DROP GENERATING DEVICE
Canada	2805425	ADMINISTRATION DE MEDICAMENT OPHTALMIQUE (OPHTHALMIC DRUG DELIVERY)

Supplementary Protection Certificates for MYDCOMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728